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FDA 510(k)

Advisor VL Circular Mapping Catheter, Sensor Enabled

K-Number: K192037 · 2019-09-17

ApplicantABBOTT MEDICAL
Decision Date2019-09-17
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advisor VL Circular Mapping Catheter, Sensor Enabled is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K192037. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advisor VL Circular Mapping Catheter, Sensor Enabled?

Advisor VL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K192037.

When did Advisor VL Circular Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?

Advisor VL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2019-09-17, under 510(k) number K192037.

Who is the listed applicant for Advisor VL Circular Mapping Catheter, Sensor Enabled?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advisor VL Circular Mapping Catheter, Sensor Enabled?

The FDA product code for Advisor VL Circular Mapping Catheter, Sensor Enabled is DRF.

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Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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